What is FDA product code QIH?

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Radiology › Image Processing and StorageAutomated Radiological Image Processing Software

TumorSight Viz

Name: TumorSight Viz
Brand: TumorSight Viz

TumorSight Viz is an image processing system designed to assist in the visualization and analysis, of breast DCE-MRI studies. TumorSight reads DICOM magnetic resonance images. TumorSight…

Registry build 21.09.26

TumorSight Viz is an image processing system designed to assist in the visualization and analysis, of breast DCE-MRI studies. TumorSight reads DICOM magnetic resonance images. TumorSight processes and displays the results on the TumorSight web application. Available features support: 1) Visualization (standard image viewing tools, MIPs, and reformats) 2) Analysis (registration, subtractions, kinetic curves, parametric image maps, segmentation and 3D volume rendering) The TumorSight system consists of proprietary software developed by SimBioSys, Inc. hosted on a cloud-based platform and accessed on an off-the-shelf computer

8manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Beijing (4), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QIH
Manufacturer	City	Province	Registered as	Device types
Philips Ultrasound (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	5
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57
GE Hangwei Medical Systems Co., Ltd.	Beijing	Beijing	Specification developer	22
GE Healthcare (China) Co., Ltd.	Beijing	Beijing	Specification developer	22
Shanghai United Imaging Healthcare Co., Ltd.	Shanghai	Shanghai	Manufacturer	12
Beijing Infervision Healthcare Medical Technology Co., Ltd.	Beijing	Beijing	Complaint-file establishment	4
Wuhan United Imaging Healthcare Co., Ltd.	Wuhan	Hubei	Manufacturer	4
Keya Medical Technology Co., Ltd.	Beijing	Beijing	Manufacturer	2

Record

Regulatory record for TumorSight Viz
Listed by	Simbiosys, Inc., United States
FDA product code	QIH
Device type	Automated Radiological Image Processing Software
Device class	Class 2
Regulation	21 CFR 892.2050
Establishment	Manufacturer
Record published	2024-06-03
Record revised	2026-06-22 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for TumorSight Viz
Catalogue number	Size	Status
V1.1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Imbio RV/LV	Imbio, LLC	5
VEA Align	EOS imaging	4
Qlab Advanced Quantification Software	Philips Ultrasound LLC	3
uOmnispace	Shanghai United Imaging Healthcare Co., Ltd.	3
Scenium	Siemens Medical Solutions USA, Inc.	3
syngo.MI General	Siemens Medical Solutions USA, Inc.	3
Neosoma Dashboard	Neosoma, Inc.	3
BriefCase-Quantification	Aidoc Medical Ltd.	3
OrthoNext™ Platform System Software	Orthofix SRL	3
MI View&GO	Siemens Medical Solutions USA, Inc.	3
FEops	Feops NV	3
AI-Rad Companion Brain MR	Siemens Healthcare Limited	3

Showing 12 of 147. All products under Automated Radiological Image Processing Software

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K251766	2025-07-08
K243189	2024-10-25
K231130	2023-12-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.